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"Cardiovascular events associated
with rofecoxib in a colorectal adenoma chemoprevention trial,"
by Robert S. Bresalier and 11 others, for the Adenomatous Polyp Prevention on
Vioxx (APPROVe) Trial Investigators, New England Journal of Medicine,
352(11): 1092-1102, 17 March 2005.
[Authors' affiliations: 8 U.S. and European
institutions]
Abstract:
"BACKGROUND: Selective inhibition of cyclooxygenase-2 (COX-2) may be
associated with an increased risk of thrombotic events, but only limited
long-term data have been available for analysis. We report on the
cardiovascular outcomes associated with the use of the selective COX-2
inhibitor rofecoxib in a long-term, multicenter, randomized,
placebo-controlled, double-blind trial designed to determine the effect of
three years of treatment with rofecoxib on the risk of recurrent neoplastic
polyps of the large bowel in patients with a history of colorectal adenomas.
METHODS: A total of 2586 patients with a history of colorectal adenomas
underwent randomization: 1287 were assigned to receive 25 mg of rofecoxib
daily, and 1299 to receive placebo. All investigator-reported serious adverse
events that represented potential thrombotic cardiovascular events were
adjudicated in a blinded fashion by an external committee. RESULTS: A total of
46 patients in the rofecoxib group had a confirmed thrombotic event during
3059 patient-years of follow-up (1.50 events per 100 patient-years), as
compared with 26 patients in the placebo group during 3327 patient-years of
follow-up (0.78 event per 100 patient-years); the corresponding relative risk
was 1.92 (95 percent confidence interval, 1.19 to 3.11; P=0.008). The
increased relative risk became apparent after 18 months of treatment; during
the first 18 months, the event rates were similar in the two groups. The
results primarily reflect a greater number of myocardial infarctions and
ischemic cerebrovascular events in the rofecoxib group. There was earlier
separation (at approximately five months) between groups in the incidence of
nonadjudicated investigator-reported congestive heart failure, pulmonary
edema, or cardiac failure (hazard ratio for the comparison of the rofecoxib
group with the placebo group, 4.61; 95
percent confidence interval, 1.50 to 18.83). Overall and cardiovascular
mortality was similar in the two groups. CONCLUSIONS: Among patients with a
history of colorectal adenomas, the use of rofecoxib was associated with an
increased cardiovascular risk."
This 2005 report from the New England
Journal of Medicine was cited 58 times in current journal
articles indexed in the Thomson Scientific database during July-August 2006.
No other medicine paper published in the last two years (excluding reviews)
attracted as many citations during that two-month period. Prior to the most
recent bimonthly count, citations to the paper have accrued as follows:
May-June 2006: 41 citations
March-April 2006: 42
January-February 2006: 33
November-December 2005: 21
September-October 2005: 33
July-August 2005: 23
May-June 2005: 9
March-April 2005: 9
Total citations to date: 269
SOURCE: Hot
Papers Database (Included with a subscription to the print newsletter Science
Watch®, available from the
Research Services Group. Packaged on a CD that is mailed with each Science
Watch issue, the Hot
Papers Database contains data on hundreds of highly cited papers published
during the last two years. User interface permits searching by author,
organization, journal, field, and more. Total citations, as well as citations
accrued during successive bimonthly periods, can be assessed and graphed. An
updated CD containing the most recent bimonthly data is mailed with every new
issue of Science
Watch,
six times a year. The CD also includes an electronic version of the Science
Watch
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